Veradermics Launches Phase 2/3 Trial for VDPHL01, a Potential First FDA-Approved Oral Treatment for FPHL

Veradermics, Inc., a dermatologist-founded biopharmaceutical company focused on high-unmet-need dermatologic conditions, has launched enrollment in its phase 2/3 registration-directed clinical trial evaluating VDPHL01, an extended-release oral formulation of minoxidil, for female pattern hair loss (FPHL).¹ This is the first late-stage US clinical trial of an oral treatment specifically for FPHL and marks a significant milestone in a field where therapeutic innovation has remained limited for decades.

“For too long, women have shouldered a significant physical and emotional burden of hair loss. I’ve seen their distress first-hand – managing their confidence, anxiety and shift in self-identity – while cycling through sub-optimal treatments, including over-the-counter, off-label and topical formulations that have limitations in addressing the challenges of hair regrowth,” said Maryanne Makredes Senna, MD, board-certified dermatologist at Beth Israel Lahey Health, assistant professor of dermatology at Harvard Medical School and a member of Veradermics’ scientific advisory board. “The Phase 2/3 female trial of VDPHL01 represents a major milestone for the industry and for women – providing the clinical rigor long overdue in female pattern hair loss. I've been encouraged by the early male data, and am hopeful that we are laying the foundation for an innovative, prescription oral treatment that, if approved, patients and healthcare providers can more confidently count on.”¹

The Phase 2/3 Registration Program

The newly initiated double-blind, randomized trial (NCT07146022) is part of a broader phase 3 program that includes three registration-directed studies in both women and men with pattern hair loss. Veradermics plans to enroll over 500 women, making it one of the most comprehensive clinical investigations in the history of FPHL. Despite women representing 85% of the US aesthetics market and the majority of hair supplement users, the field has seen no FDA-approved prescription therapy for FPHL in more than 30 years.

In parallel with the phase 2/3 program, the company is conducting an open-label, multi-dose phase 2 trial in both women and men with mild-to-moderate pattern hair loss who are not receiving other active treatments. The female cohort (n = 22) has completed enrollment, with dosing ongoing over a 12-month period. Primary endpoints include non-vellus target area hair count and patient-reported outcomes on perceived effectiveness. Veradermics also recently released encouraging preliminary findings from the male cohort, showing early visible and measurable improvement as soon as 2 months after treatment initiation. Full results from both male and female cohorts are expected in 2026.

Addressing the Unmet Need

Pattern hair loss affects an estimated 80 million people in the United States, including 30 million women. Despite its high prevalence and substantial psychosocial impact—including depression, low self-esteem, and social withdrawal—women have historically had few evidence-based therapeutic options. Currently, the only FDA-approved therapy for FPHL is topical 5% minoxidil, which offers modest efficacy and suffers from adherence issues; up to 86% of users discontinue treatment due to inconvenience and cosmetic drawbacks. Furthermore, the pattern hair loss global market is projected to reach $30 billion by 2028. Current treatment approaches include nutraceuticals with inconsistent clinical benefit and off-label pharmacologic options with variable safety and efficacy.

A New Approach to Oral Minoxidil Delivery

VDPHL01 aims to address this gap as a non-hormonal, extended-release, oral minoxidil tablet designed to optimize systemic exposure while minimizing peak-related adverse effects seen with immediate-release minoxidil. Using a proprietary gel-matrix delivery system, the formulation maintains sustained plasma concentrations above the threshold associated with hair growth while avoiding high peaks that may drive cardiovascular side effects. Promising results in patients with androgenetic alopecia were presented at this year’s European Academy of Dermatology and Venereology (EADV) Congress.² If approved, VDPHL01 would represent the first prescription oral therapy for women with pattern hair loss.

“Female pattern hair loss has many nuances – from differences in symptoms and presentation to underlying causes – and little has been done to advance research or understanding in this area. As a result, women have been left with few treatment options, none of which are consistently effective and only one that is clinically validated,” said Reid Waldman, MD, CEO of Veradermics. “At Veradermics, we are committed to bringing scientific rigor and therapeutic innovation to an aesthetic condition where women have been underrepresented and at times even excluded from early drug development. We are incredibly excited about the potential of VDPHL01 to close the long-standing gap in care for both women and men.”¹

References

1. Veradermics Advances VDPHL01 in Phase 2/3 Clinical Trial for Female Pattern Hair Loss, Marking a Milestone in the Development of the Potential First-Ever Oral Prescription Treatment for Women. News release. Business Wire. Published November 18, 2025. Accessed November 18, 2025. https://www.businesswire.com/news/home/20251118317254/en/Veradermics-Advances-VDPHL01-in-Phase-23-Clinical-Trial-for-Female-Pattern-Hair-Loss-Marking-a-Milestone-in-the-Development-of-the-Potential-First-Ever-Oral-Prescription-Treatment-for-Women

2. Shapiro J, Senna M, Muller-Ramos P, Lo Sicco K. Comparative efficacy of an investigational oral minoxidil extended-release tablet (VDPHL01) versus existing minoxidil formulations in androgenetic alopecia: a blinded retrospective IGA analysis. Presented at: European Academy of Dermatology and Venereology Congress 2025; September 17-20, 2025; Paris, France.